Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery

Sun Yat-sen University

Status: Unknown

Conditions: Rectal Cancer

Treatments: Procedure: Preservation of Denonvilliers Fascia; Procedure: Excision of Denonvilliers Fascia

Study type: Interventional

Funder types: Other

Identifiers

NCT02311803

PED-PANP001

Details and patient eligibility

About

TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. PANP (pelvic autonomic nerve preservation) surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent open (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).

In the early stage of work, the investigators performed preservation of Denovilliers' fascia in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm the early work, the investigators design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between preservation and excision of Denovilliers' fascia in L-PANP-TME.

Enrollment: 172 estimated patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age from over 20 to under 60 years;
2. Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy;
3. Mid-low rectal cancer (distance from anal edge≤12cm);
4. cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition;
5. Expected curative resection through L-PANP;
6. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
7. ASA (American Society of Anesthesiology) score class I, II, or III;
8. Written informed consent;
9. Urinary and sexual function normal preoperatively

Exclusion criteria

1. Severe mental disorder;
2. History of previous pelvic surgery;
3. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging;
4. History of other malignant disease within past five years;
5. History of unstable angina or myocardial infarction within past six months;
6. History of cerebrovascular accident within past six months;
7. History of continuous systematic administration of corticosteroids within one month;
8. Contraindication of heart, brain, lung, etc dysfunction;
9. Requirement of simultaneous surgery for other disease;
10. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer;
11. Rectal cancer invades surrounding tissues;
12. Existence of genuine incontinence or severe stress incontinence preoperatively

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 2 patient groups

Preservation of Denonvilliers Fascia

Experimental group

Description:

Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients

Treatment:

Procedure: Preservation of Denonvilliers Fascia

Excision of Denonvilliers Fascia

Active Comparator group

Description:

Excision of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients

Treatment:

Procedure: Excision of Denonvilliers Fascia